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April 2011 | In Healthcare | Comments 0
UK first to get Pharma Social Media Guidance
The PMCPA (Prescription Medicines Code of Practice Authority)have just issued a Q+A pdf describing how digital communications come under the ABPI Code of Practice - UK Pharma's self-regulation rules. The PMCPA is the first regulator to speak directly about online communications for pharmaceuticals.
The well anticipated FDA’s (US Food and Drug Administration) guide has been delayed yet again for the second time in four months leaving a swarm of pharmaceutical companies in ‘Online Limbo’, despite the fact that they issued a statement saying “Policy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities, Despite our limited resources and increasing workload” (Pharamalot, 2011). In fact, rumours have begun to circulate that they report won’t be published until 2013. With the online world moving a lightening speed, the usefulness of this FDA document seems to be is depreciating in value by the day.
Rather than issuing a complex set of procedures, The PMCPA have decided to issue a Q+A document about how online communications fits into the current UK regulation, reasoning that they haven’t had many complaints about digital communications so it should suffice. The Q+A deals with the idea of Twitter and Wikipedia in particular- For example, there is a question relating to whether company’s could change incorrect or misleading information on certain websites such as Wikipedia.
Ipha (Irish Pharmaceutical Healthcare Association) have not issued a document about online media nor have they announced plans to do so, despite the fact that they are themselves using social media- having launched medicines.ie on Facebook (ipha.ie).Therefore it’s advisable for the Irish Pharma professionals to read the UK guidelines when planning a social media campaign if they are looking for regulation guidance.
A copy of the pdf can be found here.
UPDATE: On June 13th 2011, the ABPI (The Association of the British Pharmaceutical Industry) produced "Guidance notes on the management of adverse events and product complaints from pharmaceutical company sponsored websites". The introduction states: The ABPI Pharmacovigilance Expert Network (PEN) recognises the value of using social media to communicate externally with customers. Despite the obvious benefits of using social media, there are regulatory and legal considerations due to the inherent nature of this channel. Attention to company values, legal and policy requirements are necessary for successful participation in the social media environment. These guidance notes provide suggested best practices for the monitoring and management of adverse events (AEs) and product complaints (PCs) from social media use in company sponsored websites. They have been developed by the ABPI and shared with the Medicines and Healthcare Products Regulatory Agency (MHRA)."
To read the guidance notes click here.
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